UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003670 |
|---|---|
| Receipt number | R000004449 |
| Scientific Title | A Randomized Phase II/III Trial of Tri-weekly Intravenous versus Tri-weekly Intraperitoneal Carboplatin Both in Combination with Weekly Intravenous Paclitaxel for Newly Diagnosed Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer |
| Date of disclosure of the study information | 2010/06/01 |
| Last modified on | 2023/10/06 16:02:30 |
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Basic information
Public title
A Randomized Phase II/III Trial of Tri-weekly Intravenous versus Tri-weekly Intraperitoneal Carboplatin Both in Combination with Weekly Intravenous Paclitaxel
for Newly Diagnosed Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Acronym
IntraPeritoneal therapy for Ovarian Cancer with Carboplatin Trial
Scientific Title
A Randomized Phase II/III Trial of Tri-weekly Intravenous versus Tri-weekly Intraperitoneal Carboplatin Both in Combination with Weekly Intravenous Paclitaxel
for Newly Diagnosed Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Scientific Title:Acronym
IntraPeritoneal therapy for Ovarian Cancer with Carboplatin Trial
Region
| Japan | Asia(except Japan) | North America |
Condition
Condition
Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of tri-weekly intravenous versus tri-weekly intraperitoneal Carboplatin both in combination with weekly intravenous Paclitaxel in newly diagnosed epithelial Ovarian, Fallopian tube, and primary peritoneal cancer.
Basic objectives2
Others
Basic objectives -Others
To evaluate efficacy and safety of IP Carboplatin therapy for Ovarian, Fallopian tube, and primary peritoneal cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II,III
Assessment
Primary outcomes
PhaseII - Adverse event
PhaseIII - Progression Free Survival (PFS)
Key secondary outcomes
Overall Suvival
Tumor Response
Adverse event
Treatment completion rate
Quality of Life
Cost effective
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tri-weekly Intravenous Carboplatin Both in Combination with Weekly Intravenous Paclitaxel
Interventions/Control_2
Tri-weekly Intraperitoneal Carboplatin Both in Combination with Weekly Intravenous Paclitaxel
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Patient assumed to have a stage II-IV epithelial ovarian, Fallopian tube, or primary peritoneal cancer as a pre-surgery diagnosis
2) Patient scheduled to undergo laparotomy
(*Both optimal and suboptimal patients will be eligible to the study)
3) ECOG Performance Status: 0-2
4) Patient consented to place the IP implantable port system, if assigned to IP treatment regimen
5) Patient expected to receive the first study treatment within 8 weeks after the comprehensive staging surgery
6) Reasonable organ function: Must be assessed within 28 days prior to Laparotomy
7) Patient expected to survive longer than 3 months from the starting date of the protocol therapy
8) Age: 18 or older
9) Patient must have signed informed consent.
Key exclusion criteria
1) Patients assumed to have a borderline malignancy of the ovary, fallopian tube, or primary peritoneal cancer
2) Patients who have received previous chemotherapy or radiation therapy to treat the current disease
3) Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy (Patients with basal and squamous cell carcinoma of the skin, as well as carcinoma in situ, and intramucosal carcinoma cured by local treatment, are eligible for the study)
4) Patients with serious medical complications, such as serious heart disease, cerebrovascular accidents, uncontrolled diabetes mellitus, uncontrolled hypertension, pulmonary fibrosis, interstitial pneumonitis, active bleeding, an active gastrointestinal ulcer, or a serious neurological disorder
5) Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil
6) Patients with a pleural effusion requiring continuous drainage
7) Patients with an active infection requiring antibiotics
8) Patients who are pregnant, nursing or of child-bearing potential
9) Patients with evidence upon physical examination of brain tumor and any brain metastases
10) Patients for whom completion of this study and/or follow-up is deemed inappropriate for any reason
11) Patients with any signs/symptoms of interstitial pneumonia
Target sample size
654
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Fujiwara |
Organization
Saitama Medical University International Medical Center
Division name
Department of Gynecologic Oncology
Zip code
350-0197
Address
1397-1 Yamane,Hidaka-City Saitama 350-1298
TEL
042-984-4111
iPocc@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Syoji |
| Middle name | |
| Last name | Nagao |
Organization
Okayama University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kitaku, Okayama 700-8558
TEL
086-235-7328
Homepage URL
iPocc@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Gynecologic Oncology Trial and Investigation Consortium / Japanese Gynecologic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development(AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
Gynecologic Oncology Trial and Investigation Consortium/Japanese Gynecologic Oncology Group
IRB Contact (For public release)
Organization
Saitama Medical University IRB
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
Tel
049-276-1662
tokutei@saitama-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01506856
Org. issuing International ID_1
Clinical.gov
Study ID_2
jRCTs031180141
Org. issuing International ID_2
Japan Registry of Clinical Trials
IND to MHLW
Institutions
Institutions
埼玉医科大学国際医療センター（埼玉県）
自治医科大学付属病院(栃木県）
独立行政法人国立病院機構四国がんセンター（愛媛県）
東北大学病院（宮城県）
新潟県立がんセンター 新潟病院（新潟県）
鳥取市立病院（鳥取県）
群馬大学医学部附属病院（群馬県）
広島県厚生農業協同組合連合会 広島総合病院（広島県）
市立三次中央病院（広島県）
筑波大学附属病院（茨城県）
新潟大学医歯学総合病院（新潟県）
市立貝塚病院（大阪府）
埼玉医科大学総合医療センター（埼玉県）
横浜市立市民病院（神奈川県）
大阪国際がんセンター（大阪府）
奈良県立医科大学附属病院（奈良県）
公益財団法人がん研究会 有明病院（東京都）
独立行政法人国立病院機構呉医療センター・中国がんセンター（広島県）
岩手医科大学附属病院（岩手県）
済生会長崎病院（長崎県）
慈恵医科大学病院（東京都）
慈恵医科大学付属柏病院（千葉県）
東京慈恵会医科大学附属第三病院（東京都）
群馬県立がんセンター（群馬県）
昭和大学病院(東京都)
兵庫医科大学病院（兵庫県）
独立行政法人国立病院機構 九州医療センター（福岡県）
東海大学医学部附属病院（神奈川県）
愛知県がんセンター（愛知県）
三重大学医学部附属病院（三重県）
大阪大学医学部附属病院（大阪府）
慶應義塾大学病院（東京都）
大阪医科大学（大阪府）
東京女子医科大学東医療センター（東京都）
静岡県立静岡がんセンター（静岡県）
福井大学医学部附属病院（福井県）
Korea Cancer Center Hospital（Korea）
KK Women's and Children's Hospital（Singapore）
京都府立医科大学病院（京都府）
兵庫県立がんセンター（兵庫県）
順天堂大学医学部附属順天堂医院（東京都）
Asan Medical Center（Korea）
Gangnam Severance Hospital in Korea（Korea）
Ewha Womans University Medical Center（Korea）
National University Hospital of Singapore（Singapore）
Queen Mary Hospital
弘前大学医学部附属病院（青森県）
東京大学医学部附属病院（東京都）
University of Otago - Christchurch/Christchurch Women's Hospital（New Zealand）
University of Pittsburgh（USA）
Shinchon Severance Hospital（Korea）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
http://studyweb.kitasato-ctcc.jp/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
655
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2009 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 28 | Day |
Last modified on
| 2023 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004449
